MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL 46X18X53 HUM HEAD; EXTREMITIES, IMPLANT

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item# pm0000279; lot# 237880; comp pat mat cnv glen collins.Item# cp0000235; lot# 236700; compr cnv e1 brg.Foreign report source: (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-04258.
Event or Problem Description
It was reported patient underwent a primary tsr.Subsequently, the patient developed a rotator cuff tear resulting in antero-superior migration of the humeral head resulting in the need for revision surgery to convert to reverse tsr.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Event or Problem Description
No additional information was reported.
Additional Manufacturer Narrative
Visual examination of the provided pictures identified the explanted head and glenoid.No conclusions can be made regarding the product.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: on the ap view, the humerus is superiorly subluxed/dislocated with respect to the glenoid base plate.On the axillary view, the humerus is moderately anteriorly subluxed with respect to the glenoid base plate.No malalignment is corroborated on the transscapular y-view.The bones are intact.The hardware demonstrates no fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.It was noted by the surgeon that "he does not believe the implants were the cause of the revision surgery.At the time of the primary surgery, the patient¿s rotator cuff was intact.Over time, the patient has developed rotator cuff arthropathy causing a antero-superior subluxation of the humeral head requiring revision surgery to convert to a reverse shoulder replacement," however this was unable to be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VERSA-DIAL 46X18X53 HUM HEAD
• Common Device Name: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10938499
• Report Number: 0001825034-2020-04257
• Device Sequence Number: 641981
• Product Code: HSD
• UDI-Device Identifier: 00880304212220
• UDI-Public: (01)00880304212220
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 113042
• Device Lot Number: 599200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 87